跳至主要内容
临床试验/NCT07080918
NCT07080918已完成不适用

EFFECTS OF IRRIGATION NEEDLES WITH DIFFERENT DESIGNS USED DURING ENDODONTIC TREATMENT ON POSTOPERATIVE PAIN

Akdeniz University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Assessment of postoperative pain with VAS after root canal treatment

研究概览

简要总结

This study is aimed to comparatively evaluate the effects of different irrigation needle designs used during endodontic treatment on postoperative pain and to provide information on which needle designs may be more advantageous in clinical applications based on the findings obtained.

详细描述

In this study, the mandibular molars of patients aged 18-65 who were diagnosed with symptomatic irreversible pulpitis and underwent root canal treatment at the Endodontics Clinic of Akdeniz University Faculty of Dentistry between January 2023 and January 2024 were included. Postoperative pain assessment forms obtained during the routine follow-up of the patients were included in the study.The study included patients who underwent routine root canal treatment procedures at the Endodontics clinic of Akdeniz University Faculty of Dentistry, where the treatments were performed by a single dentist. The age, gender, systemic diseases, root canal structure, periapical condition, irrigation needle design used during endodontic treatment, and pre- and post-treatment pain severity of the patients included in the study were obtained from patient records and follow-up forms.

Before the procedure, the patients' medical and dental histories were taken, and preoperative pain levels were recorded. Each patient received an inferior alveolar nerve block using a 2 ml local anesthetic solution (Ultracain D-S forte, Sanofi, France) containing 80 mg articaine hydrochloride and 0.024 mg epinephrine hydrochloride. After the teeth related to the rubber dam were isolated, caries and any existing restorations were removed using diamond burs, and a standard endodontic access cavity was prepared.

For canal length determination, #10 K-type (Perfect, China) hand files were used, and the working length was determined with an electronic apex locator (Woodpecker, Endo Radar Pro, China) and confirmed radiologically.

Root canal preparation was performed using an endodontic motor (Woodpecker, Endo Radar Pro, China) and a nickel-titanium rotary instrument system (Scope Endodontic System, Turkey) at a speed of 300 rpm and a torque of 2 N/cm. Apical preparation was completed to a size three larger. During shaping, at the point where apical resistance was encountered, excessive torsional loading was prevented by removing the files from the canal, cleaning the debris from the files, and irrigating the root canals.

During the shaping process, the root canals were rinsed with 2 ml of 2.5% NaOCl after each file change and recapitulated with a #10K file. After the root canal preparation procedure was completed, each canal was rinsed with 5 ml of 2.5% NaOCl, and the NaOCl solution was activated using an endoactivator in three 20-second cycles. 5 ml of distilled water was applied to remove NaOCl residues from the canal. Then, 2 ml of 17% EDTA (Endo-Solution, Cerkamed, Stalowa Wola, Poland) was applied for 1 minute. To neutralize the EDTA residues, each canal was finally irrigated with 5 ml of distilled water.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy patients ranging between 18 and 65 years in age,
  • •Patients with preoperative pain score ranging from moderate to severe (4-10) on a visual analog scale (VAS, 0-10)
  • •Mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis

排除标准

  • •Patients with systemic diseases,
  • •Pregnancy or lactation
  • •Teeth with periapical lesions,
  • •Teeth that previous root canal treatment,
  • •Teeth with calcified canals,
  • •Teeth with periodontal diseases,
  • •Teeth with sensitivite to percussion and palpation,
  • •Teeth with bruxism/traumatic occlusion,
  • •Teeth with crown or root fractures,
  • •Teeth with internal or external resorption,
  • •Teeth with immature/open apex,
  • •Patients who had taken antibiotics in the last two weeks,
  • •Patients who had taken analgesic or anti-inflammatory drugs within the last 12 hours,
  • •Patients missing consent and follow-up forms.

研究组 & 干预措施

Group 1

Experimental

For group 1, an open-ended notched irrigation needle (Endo-Top, Cerkamed, Stalowa Wola, Poland)Raito, China)

干预措施: Irrigation (Procedure)

Group 2

Experimental

For group 2, a closed-ended single orifice irrigation needle (Scope Endo Fx Ject, Turkey)

干预措施: Irrigation (Procedure)

Group 3

Experimental

For group 3,a closed-ended double orifice irrigation needle (Double Sideport, Raito, China)

干预措施: Irrigation (Procedure)

结局指标

主要结局

Assessment of postoperative pain with VAS after root canal treatment

时间窗: 6, 24, 48, 72 hours, and on the 7th day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Damla Kırıcı

Damla Kırıcı

Akdeniz University

研究点 (1)

Loading locations...

相似试验